PMID- 32216028
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20230829
IS  - 1538-7836 (Electronic)
IS  - 1538-7836 (Linking)
VI  - 18
IP  - 7
DP  - 2020 Jul
TI  - Anti-factor IIa (FIIa) heparin assay for patients on direct factor Xa (FXa) 
      inhibitors.
PG  - 1653-1660
LID - 10.1111/jth.14806 [doi]
AB  - BACKGROUND: Direct factor Xa (FXa) inhibitors are increasingly prescribed for 
      outpatients, and those transitioning to unfractionated heparin (UFH) for hospital 
      admission are monitored via an anti-FXa assay. Because of assay interference, UFH 
      results would often be critically elevated, confounding dosing. OBJECTIVES: An 
      anti-factor IIa (FIIa) UFH assay was evaluated for clinical use. METHODS: The 
      BIOPHEN ANTI-IIa (Aniara Diagnostica) assay and anti-FXa INNOVANCE Heparin assay 
      (Siemens Healthcare Diagnostics Products GmbH) were compared on the Siemens BCS 
      XP system. Samples included UFH controls and calibrators and specimens from 
      patients transitioning from apixaban or rivaroxaban to UFH. Method comparison, 
      linearity, recovery, precision, and interference by direct FXa inhibitors were 
      evaluated. The effect of the BIOPHEN ANTI-IIa assay on the rate of critically 
      high UFH results was retrospectively reviewed 4 months after implementation. 
      RESULTS: Accuracy studies using 0.24 and 0.50 IU/mL UFH yielded means and 
      standard deviations of 0.26 +/- 0.01 and 0.58 +/- 0.01 IU/mL, respectively. 
      Within-run and between-run coefficients of variation were 4.6% and 15.5% for the 
      low control, and 1.8% and 10.6% for the high control. The method comparison slope 
      was 0.9965 (r(2)  = 0.9468). The linear range was 0.1 to 1.3 IU/mL. The assay 
      measured UFH in the presence of 192 ng/mL apixaban or 158 ng/mL rivaroxaban. 
      Introduction of the assay for clinical use reduced the monthly percentage of 
      critically high results from 9.4% to 3.8% for admitted heparinized patients who 
      recently discontinued apixaban or rivaroxaban. CONCLUSIONS: The BIOPHEN ANTI-IIa 
      assay is suitable for patients transitioning off apixaban or rivaroxaban.
CI  - (c) 2020 International Society on Thrombosis and Haemostasis.
FAU - Stuart, Morgan
AU  - Stuart M
AD  - Special Coagulation Laboratory, Department of Pathology, University of Michigan 
      Medical School, Ann Arbor, MI, USA.
FAU - Johnson, Linda
AU  - Johnson L
AD  - Special Coagulation Laboratory, Department of Pathology, University of Michigan 
      Medical School, Ann Arbor, MI, USA.
FAU - Hanigan, Sarah
AU  - Hanigan S
AD  - College of Pharmacy, University of Michigan Medical School, Ann Arbor, MI, USA.
FAU - Pipe, Steven W
AU  - Pipe SW
AUID- ORCID: 0000-0003-2558-2089
AD  - Special Coagulation Laboratory, Department of Pathology, University of Michigan 
      Medical School, Ann Arbor, MI, USA.
AD  - Department of Pediatrics, University of Michigan Medical School, Ann Arbor, MI, 
      USA.
FAU - Li, Shih-Hon
AU  - Li SH
AUID- ORCID: 0000-0003-4538-8339
AD  - Special Coagulation Laboratory, Department of Pathology, University of Michigan 
      Medical School, Ann Arbor, MI, USA.
LA  - eng
PT  - Journal Article
DEP - 20200504
PL  - England
TA  - J Thromb Haemost
JT  - Journal of thrombosis and haemostasis : JTH
JID - 101170508
RN  - 0 (Anticoagulants)
RN  - 0 (Factor Xa Inhibitors)
RN  - 9005-49-6 (Heparin)
RN  - EC 3.4.21.6 (Factor Xa)
SB  - IM
MH  - Anticoagulants
MH  - Blood Coagulation Tests
MH  - *Factor Xa
MH  - Factor Xa Inhibitors
MH  - *Heparin
MH  - Humans
MH  - Retrospective Studies
OTO - NOTNLM
OT  - apixaban
OT  - drug monitoring
OT  - factor IIa
OT  - heparin
OT  - rivaroxaban
EDAT- 2020/03/28 06:00
MHDA- 2021/05/15 06:00
CRDT- 2020/03/28 06:00
PHST- 2020/01/21 00:00 [received]
PHST- 2020/03/12 00:00 [revised]
PHST- 2020/03/16 00:00 [accepted]
PHST- 2020/03/28 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2020/03/28 06:00 [entrez]
AID - S1538-7836(22)01324-1 [pii]
AID - 10.1111/jth.14806 [doi]
PST - ppublish
SO  - J Thromb Haemost. 2020 Jul;18(7):1653-1660. doi: 10.1111/jth.14806. Epub 2020 May 
      4.